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Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease Clinical research trials and Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease. Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease clinical trial. Human subjects often obtain the finest healthcare possible for their Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease  Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
For Condition: HIV Infections,Hodgkin's Disease
Status: Completed
Sponsor(s): Amgen , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Details: Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response. Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered.
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone. Recommended: - Antiemetic therapy within 30 minutes of chemotherapy. Allowed: - Antiretroviral medication after two cycles of chemotherapy, provided the patient has not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy. - Acetaminophen and/or nonsteroidal anti-inflammatory agents. - Bone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone. - Maintenance therapy for chronic opportunistic infection. Concurrent Treatment: Allowed: - Cranial irradiation (2400 rads) for patients with CNS involvement. Patients must have: - Documented HIV infection or diagnosis of AIDS. - Hodgkin's disease. - Consent of parent or guardian and have care directly supervised by a pediatric oncologist if under 18 years of age. Prior Medication: Allowed: - Maintenance therapy for opportunistic infections. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Second primary cancer other than Kaposi's sarcoma that does not require systemic therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix. - Acute, active bacterial or opportunistic infection requiring ongoing therapy if such therapy has been initiated within the past 2 weeks. - Known hypersensitivity (e.g., anaphylactoid reaction, bronchospasm) to E. coli-derived proteins. Prior Medication: Excluded: - Prior chemotherapy for Hodgkin's disease. - Antiretroviral therapy within 2 weeks prior to study entry. Prior Treatment: Excluded: - Prior radiotherapy for Hodgkin's disease.
Total Enrollment: 27
Location and Contact Information:
Overall Study Official:
LevineA, Study Chair,
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, California, 900331079
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Additional Information:
Study ID Numbers: ACTG 149;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000626
Other Hiv Infections Studies:
1. An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
2. A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis after Effective Anti-HIV Therapy
3. A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
4. A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients between Ages 4 and 22 with 7 Drugs, Some at Higher than Usual Doses
5. An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients with Progressive HIV Disease
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Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
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